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FDA tightens requirements for COVID vaccine, adding trials for healthy adults
The U.S. Food and Drug Administration on Tuesday said it plans to require new clinical trials for approval of annual COVID-19 ...
Trump Administration Toughens Requirements for Covid Vaccine Approval
Agency will ask drugmakers for large trials for new versions of vaccines meant for healthy adults and children.
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FDA lays out stricter COVID vaccine policy in pivot from 'one-size-fits-all' approach
The FDA is tightening its regulatory policy around COVID vaccines with a new framework that raises the bar for certain ...
FDA’s Makary: Covid shot guidance coming soon
FDA Commissioner Marty Makary announced Thursday that the agency will soon provide clear guidelines to vaccine manufacturers ...
FDA requires Covid vaccine makers to expand warning about risk of rare heart inflammation
The US Food and Drug Administration will now require Covid-19 vaccines from Pfizer/BioNTech and Moderna to use expanded ...
US Will No Longer Approve Covid Boosters for Healthy Kids, Adults Without New Trials
US regulators will no longer approve Covid booster shots for healthy adults and children without new studies, adding a costly ...